BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS

    MDR report key: 7037714 · Received November 16, 2017

    Report

    Report Number
    1823260-2017-02631
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 13, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    PMA / PMN Number
    K131605
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE PATIENT SAMPLE SHOWED THAT THE DOMINANT ANTIGEN REACTIVITY OF THIS PATIENT SHIFTED TO AN ANTIGEN THAT IS NOT SUFFICIENTLY REPRESENTED IN THE CMV IGG ASSAY. PRODUCT LABELING ADDRESSES THAT FALSE NEGATIVE RESULTS CAN OCCUR. THE ASSAY PERFORMS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE UNIT OF MEASURE FOR THE VIDAS CMV IGG AVIDITY TEST IS ARBITRARY U/ML. THE MEASURED AVIDITY OF 0.3 IS SCORED AS "LOW AVIDITY" WITH A CMV IGG AVIDITY OF LESS THAN 0.40 BEING SUGGESTIVE FOR A RECENT INFECTION.

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER¿S CMV IGM AND CMV IGG RESULTS WERE REPRODUCED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. FURTHER CLARIFICATION IS NOT POSSIBLE WITH THE AVAILABLE INFORMATION AND MEASURED RESULTS. THEREFORE NO PRODUCT PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS CMV IGG ASSAY (CMV IGG) AND ELECSYS CMV IGM IMMUNOASSAY (CMV IGM) ON A COBAS 8000 E 801 MODULE WITH A SERIAL NUMBER OF (B)(4). OF THE DATA PROVIDED ONLY THE FALSE NEGATIVE RESULT FOR CMV IGG IS A REPORTABLE MALFUNCTION. ON (B)(6) 2017 SAMPLE A HAD A CMV IGG RESULT FROM A COBAS E801 OF 1.16 U/ML (POSITIVE). ON (B)(6) 2017 A NEW SAMPLE WAS DRAWN, SAMPLE B, AND THE CMV IGG INITIAL AND RERUN RESULTS FROM A COBAS E801 WERE 0.324 U/ML (NEGATIVE) AND 0.315 U/ML (NEGATIVE). SAMPLE B WAS TESTED ON A VIDAS SYSTEM IN THE SAME LABORATORY WITH A CMV IGG RESULT OF 10 AU/ML (POSITIVE). SAMPLE B WAS ALSO TESTED ON A VIDAS SYSTEM IN ANOTHER LABORATORY WITH A CMV IGG RESULT OF 10 AU/ML (POSITIVE). ALSO ON THE VIDAS SYSTEM IN ANOTHER LABORATORY A CMV IGG AVIDITY RESULT OF 0.30 (UNITS NOT PROVIDED) WAS OBTAINED. SAMPLE B WAS TESTED ON A LIASON XL-DIASORIN IN ANOTHER LABORATORY WITH A CMV IGG RESULT OF 50.8 AU/ML (POSITIVE). IT WAS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER IS UNABLE TO MAKE A CONCLUSIVE DECISION. THE INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817446 CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 212200

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR